- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404127
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients - Prospective Randomized Double Blind Controlled Clinical Trial
Background:
Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not fully investigated
Aims:
To compare different induction therapeutic strategies with 2 doses of Basiliximab vs. no induction) in low immunologic risk kidney transplant recipients as per KFSHRC protocol (Appendix 2)
Methods:
Prospective, randomized, double blind, non-inferiority, controlled clinical trial
Expected Outcomes:
Primary outcomes:
Biopsy proven acute rejection within first year following transplant
Secondary outcomes:
- Patient and graft survival at 1 year
- Estimated glomerular filtration rate (eGFR) at 6 months and at 12 months
- Emergence of de novo donor specific antibodies (DSAs)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Riyadh, Saudi Arabia, 11211
- Recruiting
- King Faisal Specialist Hospital and Research Centre (KFSHRC)
-
Contact:
- Aziza Ajlan, B.Sc. Pharm. BCPS
- Phone Number: 80341 966114647272
- Email: aajlan@kfshrc.edu.sa
-
Principal Investigator:
- Aziza Ajlan, B.Sc. Pharm. BCPS
-
Principal Investigator:
- Hassan Aleid
-
Sub-Investigator:
- Tariq Ali
-
Sub-Investigator:
- Hala Joharji
-
Sub-Investigator:
- Ahmed Nazmi
-
Sub-Investigator:
- Khalid Almeshari
-
Sub-Investigator:
- Edward Devol
-
Sub-Investigator:
- Dalal Alkortas,
-
Sub-Investigator:
- Zinah Alabdulkarim
-
Sub-Investigator:
- Yaser Shah
-
Sub-Investigator:
- Ibrahim Alahmadi
-
Sub-Investigator:
- Asad Ullah
-
Sub-Investigator:
- Ahmed Aljedai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Male or female ≥ 18 years
- Living donor
Low immunological risk (defined as):
- First (primary) transplant
- ≤ 4 antigen mismatches (HLA matching scheme)
- Negative HLA Ab screening
Exclusion Criteria:
• High immunological risk
- HLA identical or zero mismatched transplants
- Receiving cyclosporin as primary maintenance immunosuppressant
- Human immunodeficiency virus (HIV) co-infection
- Pregnant or nursing female
- Has received an investigational medication within the past 30 days
- Has a known contraindication to the administration of Basiliximab
- Suspected or known to have a serious infection
- Multi-organ transplant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: No induction Arm
|
No-Induction
|
Active Comparator: Induction with basiliximab
|
Basiliximab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of biopsy proven acute rejection within first year following transplant
Time Frame: 1 year after transplant
|
1 year after transplant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of graft survival at 1 year
Time Frame: 1 year after transplant
|
1 year after transplant
|
Rate of decline in eGFR at 6 months and at 12 months
Time Frame: 1 year after transplant
|
1 year after transplant
|
Rate of emergence of de novo donor specific antibodies (DSAs)
Time Frame: 1 year after transplant
|
1 year after transplant
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAC # 2191177
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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